Benzinga | Jul 27, 2021 11:13AM EDT

BioVie Highlights Presentation Of Data On NE3107 As Treatment For Alzheimer's Disease

BioVie Inc., a clinical-stage company developing innovative drug therapies for the treatment of liver disease, neurodegenerative disease and certain cancers, announced today that a poster by Christopher L Reading, PhD, BioVie's Executive Vice President for Neuroscience Research & Development was presented at the 2021 Alzheimer's Association International Conference (AAIC).

Poster 55458 entitled "Rationale for an anti-inflammatory insulin sensitizer in a phase 3 Alzheimer's Disease trial" highlighted the safety profile and broad mechanism of action against features of Alzheimer's Disease of NE3107--an oral small molecule, blood-brain permeable anti-inflammatory insulin sensitizer that binds ERK. NE3017 has also been shown to selectively inhibit inflammation-driven ERK- and NF?B-stimulated inflammation without inhibiting their homeostatic functions. In prior animal studies and Phase 1 and 2 human clinical trials, NE3107 has been demonstrated to be safe and effective at reducing neuroinflammation and insulin resistance, both of which are recognized as important players in Alzheimer's Disease pathology.

BioVie has obtained authorization from the U.S. Food & Drug Administration to initiate a pivotal Phase 3 trial of NE3107 in Alzheimer's Disease called the NM101 study (NCT04669028). NM101 is a randomized double blind, placebo-controlled, US multicenter study of NE3107 in 316 subjects with mild to moderate Alzheimer's Disease. In addition to conventional cognition, memory, functional, behavioral and imaging end points, NM101 will assess measures of glycemic control, brain glucose utilization and systems dysregulation. The basis for this study design was recently published in a peer-reviewed article in Neurodegenerative Disease Management ( https://doi.org/10.2217/nmt-2021-0022). The study is actively recruiting and screening patients and aims to have data readout by the end of 2022.

At the AAIC this year there are literally hundreds of presentations on inflammation and Alzheimer's disease and dozens on insulin resistance and AD.

"NE3107 is the first potentially disease modifying, anti-inflammatory insulin sensitizer therapy in a phase 3 trial," said Cuong Do, Chief Executive Officer of BioVie. "Additionally, our NM101 study is the first randomized, double blind, placebo-controlled Phase 3 trial conducted by any company to test a disease modifying anti-inflammatory insulin sensitizer therapy in subjects with mild to moderate Alzheimer's. NE3107 has been shown to decrease the inflammatory signal transduction cascades that are known to inhibit insulin action in the brain, and to restore insulin action. NE3107 blocks the major inflammatory nodes of extracellular signal-regulated kinase (ERK) and nuclear factor kappa B (NFkB). In addition, examples were presented to show that NE3107 preserves both ERK and NFkB homeostatic functions. We are initiating this trial with the aim of reading out the end of 2022."

The AAIC is being held virtually and in Denver, CO, July 26-30, 2021.